FDA Issues Draft Guidances on Clinical Data, Predicate Devices in Premarket Notifications

The U.S. Food and Drug Administration (FDA) has recently issued two draft guidance documents that may be of interest to medical device developers and manufacturers.

Issued in early September, the first draft guidance, “Recommendations for the Use of Clinical Data in Premarket Notification (510(k)) Submissions,” is intended to provide clarification on situations in which the submission of clinical data may be necessary to demonstrate “substantial equivalence” in premarket submissions.

Also issued in early September, the second draft guidance, “Best Practices for Selecting a Predicate Device to Support a Premarket Notification (510(k)) Submission,” offers four best practices that device manufacturers can apply when choosing a predicate device that has previously been cleared by the FDA in premarket submissions. The best practices include selecting predicate devices:

  • That have been cleared using well-established methods;
  • That meet or exceed expected safety and performance standards;
  • That do not have unmitigated use-related or design-related safety issues; and
  • That are not associated with a design-related recall.

Remember that guidance documents issued by the FDA and other agencies are only intended to provide insight into the current thinking of regulators and should be viewed only as recommendations and not requirements.

Read the draft guidance on the use of clinical data in premarket notification submissions.

Read the draft guidance on predicate devices.

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